Label: SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0450-01, 0135-0480-01, 0135-0480-02
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 25, 2020

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  • Active ingredient

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    •
    builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    •
    aids in the prevention of dental cavities.
  • Warnings

    Stop use and ask a dentist if

    •
    the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    •
    pain/sensitivity still persists after 4 weeks of use.

    Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    adults and children 12 years of age and older:
    •
    apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    •
    brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing
    •
    children under 12 years of age: Consult a dentist or doctor.
  • Other information

    •
    do not store above 25°C (77°F)
  • Inactive ingredients (refreshing peppermint)

    water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin

  • Inactive ingredients (whitening action)

    water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss.

    Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity.

    ACIDS DISSOLVE SURFACE MINERALS…

    …PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA

    Replenishes vital minerals in enamel.

    Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface.

    With twice-daily brushing, Pronamel helps to:

    •
    Protect against effects of dietary acids
    •
    Prevent enamel loss
    •
    Relieve sensitive teeth
    •
    Protect against cavities
    •
    Clean and freshen your mouth

    Recyclable Carton

    Save Water

    Turn off tap while brushing

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    NDC 0135-0450-01

    SENSODYNE

    PRONAMEL

    MINERAL BOOST

    new

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Replenishes Vital Minerals

    For Stronger, Healthier Enamel

    infused with refreshing peppermint

    NET WT 4.0 OZ (113g)

    gsk

    ©2020 GSK group of companies or its licensor.

    62000000049368

    Sensodyne Pronamel Mineral Boost refreshing peppermint 4.0 oz carton
  • Principal Display Panel

    NDC 0135-0480-01

    SENSODYNE

    PRONAMEL

    MINERAL BOOST

    new

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Replenishes Vital Minerals

    For Stronger, Healthier Enamel

    With gentle whitening action

    NET WT 4.0 OZ (113g)

    gsk

    ©2020 GSK group of companies or its licensor.

    62000000049369

    Sensodyne Pronamel Mineral Boost whitening action 4.0 oz carton
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  MINERAL BOOST REFRESHING PEPPERMINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0450
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0450-011 in 1 CARTON01/04/2021
    1118 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/04/2021
    SENSODYNE PRONAMEL  MINERAL BOOST WHITENING ACTION
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0480
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0480-011 in 1 CARTON01/04/2021
    1118 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0480-021 in 1 CARTON01/04/2021
    277 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/04/2021
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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